Viking Therapeutics has completed patient enrolment in a Phase ll clinical trial designed to examine the efficacy, safety and tolerability of VK2809 to treat patients with primary hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD).
As part of the randomised, double-blind, placebo-controlled, parallel-group study, patients have been randomised to take once-daily oral doses of VK2809 or placebo for 12 weeks followed by a four-week off-drug phase.
The trial's primary endpoint is to evaluate the effect of VK2809 treatment on LDL cholesterol (LDL-C) after 12 weeks compared to placebo.
The trial’s secondary and exploratory endpoints comprise assessments of changes in liver fat content, triglycerides, and other lipid markers.
Results from the trial are expected to be available in the second half of this year.
Viking Therapeutics CEO Brian Lian said: “We believe VK2809's potent activity at the thyroid beta receptor may provide benefit to patients with fatty liver disease, such as non-alcoholic steatohepatitis (NASH).
“In-vivo studies have shown that treatment with VK2809 leads to significant improvement in markers related to NASH development, severity and progression.
“In addition, prior clinical data in subjects with mild hypercholesterolemia have demonstrated that treatment with VK2809 results in significant reductions in LDL cholesterol, triglycerides and atherogenic proteins.”
VK2809 is a new, orally available small molecule thyroid receptor agonist that possesses selectivity for liver tissue, as well as the beta receptor subtype.
It has the therapeutic potential for a range of lipid disorders.
Results from a number of preclinical and clinical studies show a differentiated therapeutic profile for VK2809 relative to current development programmes targeting hypercholesterolemia and fatty liver disease, including NASH.